With the launch of the new National Pharmacovigilance Network (RNF), on 20 June 2022 the new forms for reporting suspected adverse reactions to drugs and vaccines by healthcare professionals and patients/citizens will come into force.

For online reporting, a new platform will be available on the AIFA portal, replacing the Vigifarmaco system, no longer operational since 9 June 2022 ("Come segnalare una reazione avversa").

For reporting by filling in and sending the forms to the pharmacovigilance officer (or to the marketing authorisation holder of the medicinal product), AIFA will make available the updated forms according to the new international standard format ISO Individual Case Safety Report (ICSR) ICH E2B(R3), provided for by Article 26 (2) (a) of the Implementing Regulation (EU) no. 520/2012.
As of 30 June 2022, this format will be mandatory in all EU countries for sending and receiving reports of suspected adverse reactions to and from EudraVigilance, the European database of suspected adverse reactions to medicinal products authorised or under investigation in the European Economic Area (EEA), with which the ICSR is directly linked.

The reporting forms have been graphically improved for greater usability and comprehension by compilers. Moreover, additional fields have been introduced under the new standard for the acquisition of more information on adverse reactions, suspected drugs and laboratory and/or instrumental examinations that will allow an increasingly accurate assessment of the safety profile of medicines.

The data collected within the reporting forms will be processed in accordance with the data protection rules set out in Regulation (EU) N 679/2016.

The new forms replace those currently in use and, in order to facilitate their compilation, each form is published together with a related compilation guide.